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GMP Manufacture

Public Health EnglandUnited Kingdom

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GMP Manufacture...

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We have state of the art cGMP manufacturing facilities, licensed by the MHRA and FDA at our centre at Porton Down, Salisbury for the manufacture of our own biopharmaceutical products. These include the only anthrax vaccine licensed in Europe (AVP) and ERWINASE™, a therapeutic enzyme for the treatment of acute lymphobastic leukaemia (ALL) in children. In addition to our own products, our manufacturing and filling facilities are utilised for the production of a wide range of clinical materials for our clients. Our unique containment level 3 capabilities are geared to the bespoke manufacture of low volume, high potency/toxicity bacterial products. We are able to offer customers a large range of developmental capabilities. These range from the creation of entire biopharmaceutical manufacturing schemes from research scale methodologies to the development of individual process components (eg cell bank, fermentation, purification). Our clients can benefit from our extensive experience in validating our own processes and methods. Critical process and analytical method parameters are identified at an early stage in the development cycle, operating limits defined, often using scale-down technologies, and finally verified at manufacturing scale.